Cleared Traditional

K142768 - Instru-Safe Instrument Protection System

K142768 is an FDA 510(k) clearance for Instru-Safe Instrument Protection System, manufactured by Summit Medical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K142768 · Summit Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2015
Decision
246d
Days
Class 2
Risk

K142768 is an FDA 510(k) clearance for the Instru-Safe Instrument Protection System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Summit Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 246 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Summit Medical, Inc. devices

FDA 510(k) Submission Details - K142768

510(k) Number K142768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date May 29, 2015
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K142768.
Instru-Safe Instrument Protection System
K151166 · Summit Medical, Inc. · Aug 2015
SterilContainer S System
K142970 · Aesculap, Inc. · Jul 2015
Instru-Safe Instrument Protection System
K150540 · Summit Medical, Inc. · Jun 2015
InterActive Complete Surgical Tray
K142519 · Implant Direct Sybron Manufacturing, LLC · Apr 2015
Endoscope Sterilization Tray
K142937 · Intuitive Surgical, Inc. · Feb 2015
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · Sterilucent, Inc. · Jan 2015